CORDES BPO

CORDES BPO 10% Gel

Important notes (mandatory information)

Cordes BPO 10% Gel. Active ingredient: Benzoyl peroxide. Areas of application: for all forms of endogenous acne (acne vulgaris), especially on the chest and back, as well as for patients who do not respond to lower benzoyl peroxide concentrations.

For risks and side effects, read the package leaflet and consult your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR THE USER

Cordes BPO 10% Gel
Active ingredient: Benzoyl peroxide

Read the entire package leaflet carefully before you start using this medicine, as it contains important information. Always use this medicine exactly as described in this package leaflet or exactly as directed by your doctor or pharmacist.

• Keep the package leaflet. You may need to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you experience any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. See section 4.
• If the mild skin irritation that may occur at the beginning of treatment worsens or does not subside after 5 days, the preparation should be discontinued and medical advice should be sought.

What this package leaflet contains

1. WHAT IS CORDES BPO 10% GEL AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE USING CORDES BPO 10% GEL?
3. HOW TO USE CORDES BPO 10% GEL?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE CORDES BPO 10% GEL?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS CORDES BPO 10% GEL AND WHAT IS IT USED FOR?

Cordes BP0 10% Gel is a medicine for acne (acne dermaticum) and contains the active ingredient benzoyl peroxide. CORDES® BP010 % Gel is used for all forms of endogenous acne (acne vulgaris), especially on the chest and back, as well as for patients who do not respond to lower benzoyl peroxide concentrations.

2. WHAT SHOULD YOU CONSIDER BEFORE USING CORDES BPO 10% GEL?

Cordes BPO 10% Gel must not be used if you are known to be allergic to the active ingredient benzoyl peroxide or to any of the other ingredients.

Warnings and precautions

Please talk to your doctor or pharmacist before using Cordes BPO 10% Gel. Caution is advised in patients with a predisposition to allergic eczema (atopic dermatitis) when used on dry (sebostatic) skin. Note: Cordes BPO 10% Gel must not be applied to mucous membranes or in the area of the mouth, nose and corners of the eyes. Due to the high sensitization rate, benzoyl peroxide should not be used on damaged (eroded) skin.

Use of Cordes BPO 10%

Gel together with other medicines

Tell your doctor or pharmacist if you are using, have recently used or intend to use any other medicines. Simultaneous use of other irritating topical agents and simultaneous intensive UV irradiation (sunbathing, solariums) of the skin areas treated with Cordes BPO 10% Gel should be avoided.

Pregnancy and breastfeeding

Cordes BPO 10% Gel should only be used during pregnancy and breastfeeding after careful consultation with a doctor. The preparation should not be used in the last month of pregnancy. There is no knowledge of the passage into breast milk after external treatment during pregnancy. There is also no knowledge of the concentration in breast milk during external (external) treatment during lactation (time of milk production). For these reasons, not only during pregnancy but also during the lactation phase (breastfeeding), a strict assessment of the benefit/risk ratio by the treating physician and special caution when using benzoyl peroxide is required. There is no evidence to date of any harm to the unborn child.

Driving and using machines:C
Cordes BPO 10 % Gel has no influence on the ability to drive and use machines.

Cordes BPO 10%

Gel contains propylene glycol

Propylene glycol can cause skin irritation.

3. HOW TO USE CORDES BPO 10% GEL?

Always use this medicine exactly as described in this package leaflet or exactly as agreed with your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure. Unless otherwise prescribed by your doctor, Cordes BPO 10% Gel is applied to the affected skin areas once or twice a day. Before using CORDES® BP010 % Gel, the skin should be thoroughly cleansed. The gel is then applied thinly to the skin (do not massage in) and left on the skin. After application, wash your hands thoroughly. Cordes BPO 10% Gel should not be applied to healthy skin. Initially, the frequency of application should be determined according to the skin's sensitivity and, if necessary, the treatment should be continued with a once-daily application, in the evening. For application to the skin. Cordes BPO 10% Gel should be used until the acne has improved or the skin symptoms have disappeared. Please ask your doctor about this. The average duration of treatment is 4 -10 weeks. The frequency of application depends on the type and severity of the clinical picture and on the skin reaction. Note: Due to its bleaching effect, CORDES® BP010 % Gel should not be used on the eyebrows, in the beard area or on the forehead hairline, nor should it come into contact with coloured textiles.

If you have used a larger amount of Cordes BPO 10%

Gel than you should

If skin irritation occurs, therapy should be continued with lower concentrations or discontinued. No special countermeasures are necessary.

If you forget to use Cordes BPO 10%

Gel

Do not use double the amount to make up for the missed application.

If you stop using Cordes BPO 10%

Gel

Please discuss the further procedure with your doctor, as the success of the treatment is at risk. If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Rare (1 to 10 in 10,000 treated)

In rare cases, benzoyl peroxide can lead to contact allergic sensitization. Allergic reactions are possible in case of hypersensitivity to propylene glycol. In these cases, the preparation should be discontinued and a doctor should be consulted. Note: At the beginning of treatment, mild skin irritation such as redness, itching, tightness and burning may occur as the effect sets in. These symptoms usually subside after a few days. Drying out and moderate peeling of the skin are also part of the therapeutic effect. However, if these signs persist for more than 5 days or become more severe, the preparation should be discontinued and medical advice should be sought.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. of Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: http://www.bfarm.de, by reporting side effects you can help to provide more information on the safety of this medicine.

5. HOW TO STORE CORDES BPO 10% GEL?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the carton or tube after "use by". The expiry date refers to the last day of the month indicated. After opening, you can use Cordes BPO 10% Gel until the expiry date. Do not store above 25°C.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Cordes BPO 10%

Gel contains

The active ingredient is benzoyl peroxide. 1 g of gel contains 100 mg of benzoyl peroxide. The other ingredients are: propylene glycol 0.1 g, carbomer, sodium hydroxide, purified water.

What Cordes BPO 10%

Gel looks like and contents of the pack

Glassy white gel. Cordes BPO 10% Gel is available in tubes of 30 g (N1), and 100 g (N3).

Pharmaceutical entrepreneur and manufacturer

Ichthyol-Gesellschaft Cordes Hermanni & Co. (GmbH & Co.) KG
Sportallee 85
22335 Hamburg
Tel.:040-50714-0
Fax: 040-50714-110
E-Mail: info@ichthyol.de

This leaflet was last revised in February 2014.

Source: Information from the package leaflet
Status: 10/2016
Active ingredient: Benzoyl peroxide. Areas of application: for all forms of endogenous acne (acne vulgaris), especially on the chest and back, as well as for patients who do not respond to lower benzoyl peroxide concentrations.